Effect of Estradiol Pretreatment on Antagonist ICSI Cycles

NCT05197374 | Completed Phase 4

• 1 other identifier: 0106351
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Depended on the hypothesis that growth asynchrony of antral follicles is a consequence of the gradual follicle stimulating hormone (FSH) elevation that occurs during the late luteal phase, the aim of this work is to study the effect of estradiol pretreatment on follicular synchronization and intracytoplasmic sperm injection (ICSI) outcome in antagonist cycles

Conditions

Female Infertility

Outcome Measures

Primary Outcomes (7)

• Days of stimulation.

  number of days from the start of controlled ovarian stimulation on day 2 of menses until the day of hCG administration until day of hCG administration

  7-16 days after start of controlled ovarian stimulation.

• Total number of gonadotropin ampoules used.

  number of gonadotropin ampules used from the start of controlled ovarian stimulation on day 2 of menses until the day of hCG administration

  7-16 days after start of controlled ovarian stimulation.

• Total number of follicles by U/S on day of hCG.

  number of follicles by ultrasound scan on day of hCG administration

  7-16 days after start of controlled ovarian stimulation.

• Serum estradiol and progesterone level on day of hCG .

  serum level of estradiol pg/dl and progesterone ng/dl on day of hCG administration

  7-16 days after start of controlled ovarian stimulation.

• Endometrial thickness on day of hCG.

  thickness of endometrium in mm on day of hCG

  7-16 days after start of controlled ovarian stimulation.

• Number of mature oocytes

  number of metaphase II oocytes after denudation

  36 hours after oocyte retrieval.

• Number of good quality embryos.

  number of grade 1 and grade 2 day 3 embryos

  3 days after oocyte retrieval.

Secondary Outcomes (2)

• Pregnancy rate

  14 days after embryo transfer

• Clinical pregnancy rate

  2 weeks after positive pregnancy test

Study Arms (2)

Group 1

EXPERIMENTAL

Cases who received estradiol pretreatment then underwent ICSI.

Drug: Estradiol Valerate 4mg

group 2

NO INTERVENTION

Cases who underwent ICSI directly without receiving any pretreatment

Interventions

Estradiol Valerate 4mg DRUG

Estradiol valerate 2 mg (two tablet once daily) started 5 days before expected menses (or 7 days after ovulation of previous cycle). After start of menses, estradiol pretreatment was stopped and controlled ovarian stimulation started.

Also known as: Progynova

Group 1

Eligibility Criteria

• Age: 20 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women age 20-37 years.
• Anti-mullerian (AMH) level greater than 1.2 ng/ml.
• Body mass index between 18 and 29 kg/m2.
• Undergoing a first or second ICSI cycles.

You may not qualify if:

• Endometriosis.
• Uterine disorders such as fibroids and uterine anomalies.
• Antral follicular counts (AFC) less than 10.
• Azoospermic males.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

IVF center

Alexandria, Egypt

Location

Related Publications (5)

• Devreker F, Pogonici E, De Maertelaer V, Revelard P, Van den Bergh M, Englert Y. Selection of good embryos for transfer depends on embryo cohort size: implications for the 'mild ovarian stimulation' debate. Hum Reprod. 1999 Dec;14(12):3002-8. doi: 10.1093/humrep/14.12.3002.

  PMID: 10601087 BACKGROUND

• Opsahl MS, Blauer KL, Black SH, Lincoln SR, Thorsell L, Sherins RJ. The number of embryos available for transfer predicts successful pregnancy outcome in women over 39 years with normal ovarian hormonal reserve testing. J Assist Reprod Genet. 2001 Oct;18(10):551-6. doi: 10.1023/a:1011906024170.

  PMID: 11699127 BACKGROUND

• Lee H, Choi HJ, Yang KM, Kim MJ, Cha SH, Yi HJ. Efficacy of luteal estrogen administration and an early follicular Gonadotropin-releasing hormone antagonist priming protocol in poor responders undergoing in vitro fertilization. Obstet Gynecol Sci. 2018 Jan;61(1):102-110. doi: 10.5468/ogs.2018.61.1.102. Epub 2017 Dec 19.

  PMID: 29372156 BACKGROUND

• Cedrin-Durnerin I, Guivarc'h-Leveque A, Hugues JN; Groupe d'Etude en Medecine et Endocrinologie de la Reproduction. Pretreatment with estrogen does not affect IVF-ICSI cycle outcome compared with no pretreatment in GnRH antagonist protocol: a prospective randomized trial. Fertil Steril. 2012 Jun;97(6):1359-64.e1. doi: 10.1016/j.fertnstert.2012.02.028. Epub 2012 Mar 28.

  PMID: 22464760 BACKGROUND

• Sefrioui O, Madkour A, Kaarouch I, Louanjli N. Luteal estradiol pretreatment of poor and normal responders during GnRH antagonist protocol. Gynecol Endocrinol. 2019 Dec;35(12):1067-1071. doi: 10.1080/09513590.2019.1622086. Epub 2019 May 29.

  PMID: 31142165 BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Sherif Hebisha, phD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 19, 2022
• Study Start: June 1, 2020
• Primary Completion: February 20, 2021
• Study Completion: November 15, 2021
• Last Updated: February 3, 2022

Record last verified: 2022-01

Locations

EG (1)